Head of Clinical Data Innovation

chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its headquarter in parma, italy. more than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. this is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. discover more here.

chiesi global rare diseases is a chiesi group’s business unit established in february 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available. this unit is based in boston, massachusetts, with a strong synergy with the headquarters in parma. rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. the unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. discover more here.

the head of clinical data innovation is responsible for defining and executing the clinical data innovation strategy across the global rare disease portfolio. the role drives the adoption of emerging technologies, artificial intelligence, automation, advanced analytics, and modern data management methodologies to accelerate clinical development, improve data quality, increase operational efficiency, and enhance regulatory readiness. the individual serves as a strategic bridge between clinical data management, biostatistics, statistical programming, clinical operations, digital/it, and external partners to modernize clinical data processes and establish a future-ready clinical data ecosystem. you will be responsible for

define and maintain the clinical data innovation roadmap aligned with organizational objectives. identify opportunities to leverage ai, machine learning, automation, and digital technologies across the clinical development lifecycle. establish long-term strategies for clinical data architecture, interoperability, standardization, and data reuse. serve as innovation ambassador within clinical development and across r&d.

lead evaluation, implementation, and governance of ai-enabled solutions supporting: data review & data cleaning, query generation, medical coding, risk-based quality management, database build automation, (automated) metadata generation, regulatory submission preparation; develop frameworks and standard operating procedures for responsible and compliant ai use in accordance with company governance and regulatory expectations; monitor emerging technologies and assess applicability to clinical development.

drive modernization of clinical data management processes and operating models. lead initiatives to improve scalability and efficiency across internal and outsourced studies. optimize interactions between data management, programming, biostatistics, medical writing, and clinical operations.

act as business owner and subject matter expert for clinical data technologies. collaborate with it and digital functions regarding edc platforms, data lake architectures, analytics environments, ai platforms and data visualization tools. lead vendor evaluations and technology selection processes. establish kpis demonstrating technology value and business impact.

promote use of advanced analytics and visualization to improve study oversight. enable near real-time monitoring of data quality, study conduct, operational performance and risk indicators. partner with biostatistics and programming to enhance integrated data review capabilities.

build and manage a portfolio of innovation initiatives. prioritize projects according to strategic value, feasibility, risk, and return on investment. establish business cases and success metrics for innovation projects. present innovation strategies and outcomes to senior leadership.

partner closely with stakeholders within r&d and related to r&d (i.e. clinical data management, biostatistics, statistical programming, clinical operations, regulatory affairs, quality assurance, it). build relationships with external vendors, technology providers, and industry consortia.

develop organizational capabilities in ai, automation, and innovative data practices. mentor teams on emerging technologies and new ways of working. foster a culture of experimentation, continuous improvement, and innovation. contribute to workforce planning and future capab